HVAC PHARMACEUTICAL SYSTEM

Course Overview

Brief history of HVAC systems
Uses of HVAC Systems
Key Regulations, Guidelines and Standards, Including
changes to ISO Standards
Facility Design for Particle Control
Facility layout and typical controlled area specifications
Design features for the control of contamination / cross-
Contamination:

Pressure / Airflow regimes
Control of dust and prevention of cross-contamination
Differential Pressure Regimes and room grading
Use of barrier systems and unidirectional airflow devices
Introduction to Cleanrooms

Cleanroom definition and interpretation
History of cleanrooms
The origins of today’s cleanroom air velocities, room change
rates and particle limits
Cleanroom classification and pharmaceutical cleanrooms
Achieving and maintaining cleanroom cleanliness levels
Qualification of HVAC Systems

Risk-based approach
Impact assessments
Quality Risk Assessments
IQ/OQ
Documentation examples
Fundamental Purposes of HVAC Systems
Preservation of product quality
Particle removal (effective air distribution & air change rates)
Particle and dust containment
Comfort conditions
Product related conditions
HVAC System Fundamental Components

Components/configuration of air handling system
Methods of air distribution and extraction
Typical filter regime
Types of filters
Filtration processes
Sizing/application of air handling units (AHU), e.g. one per
facility, or multiple AHUs for different grades
Control of Key Room Parameters by HVAC Systems

Differential Pressures (different control philosophies/mechanisms)
Pressure Stabilisers and controlled room leakage
Preserving room volumetric flows
Temperatures
Relative Humidity
Monitoring Systems
HVAC Maintenance Considerations :

Proactive filter changes
Cleaning
Equipment servicing
Calibration